NCT00158639

Brief Summary

The control of blood pressure (BP) for patients with hypertension on medications has been elusive, despite the availability of evidence-based nationally recognized guidelines for treatment and 30 years of research addressing this. At present, less than 50% of patients with known hypertension are adequately controlled. If BP control could be improved, significant decreases in cardiovascular morbidity and mortality would occur. The purpose of this study is to conduct a randomized controlled trial of the effectiveness of the provision of home blood pressure measurement and electronic communications (secure messaging to health care providers) to improve hypertension control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
778

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Jun 2005

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.5 years

First QC Date

September 8, 2005

Last Update Submit

October 11, 2017

Conditions

Hypertension

Keywords

Blood Pressure Monitoring, homePharmaceutical servicesSelf care

Outcome Measures

Primary Outcomes (2)

  • *change in mean diastolic, systolic, and combined diastolic and systolic BP.

  • *percent of patients with adequately controlled BP.

Secondary Outcomes (3)

  • *adherence to recommended anti-hypertensive medications and the proportion on preferred anti-hypertensive medications.

  • *patients' general health status, sense of self-efficacy in their management of hypertension, and satisfaction with their care in general and that for hypertension.

  • *to assess the impacts of each intervention on hypertension visits, primary care visits, and medication use for hypertension, and estimate the incremental cost-effectiveness of each.

Interventions

Home BP;secure messaging;pharmaceutical care;BEHAVIORAL

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hypertension in the prior two years and on hypertension medications
  • Access to the Internet and an e-mail address
  • Ability to use a computer using the English language
  • Medical care coverage which permits them to refill prescriptions at Group Health Cooperative pharmacies and a willingness to do so.
  • Blood pressure on each of two screening visits averaging \> 90 mmHg diastolic or \> 140 mmHg systolic and \< 110 mmHg diastolic or \< 200 mmHg systolic

You may not qualify if:

  • Diagnosed or history of diabetes, cardiovascular disease (ischemic heart disease, valvular heart disease, heart failure, arrhythmias, strokes or transient ischemic attacks, and peripheral vascular disease)
  • Current treatment for cancer, on immunosuppressant or antiretroviral treatment.
  • Surgery or hospitalization in the prior 3 months
  • Pregnancy (or plans to become pregnant in the next 12 months)
  • Plans to move out of the area or leave the health plan in the next 12 months.
  • Upper arm circumference size \> 18 inches.
  • Arrhythmia detected at screening visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

  • Meenan RT, Anderson ML, Chubak J, Vernon SW, Fuller S, Wang CY, Green BB. An economic evaluation of colorectal cancer screening in primary care practice. Am J Prev Med. 2015 Jun;48(6):714-21. doi: 10.1016/j.amepre.2014.12.016.

    PMID: 25998922DERIVED

  • Green BB, Anderson ML, Ralston JD, Catz SL, Cook AJ. Blood pressure 1 year after completion of web-based pharmacist care. JAMA Intern Med. 2013 Jul 8;173(13):1250-2. doi: 10.1001/jamainternmed.2013.1037. No abstract available.

    PMID: 23689927DERIVED

  • Green BB, Anderson ML, Ralston JD, Catz S, Fishman PA, Cook AJ. Patient ability and willingness to participate in a web-based intervention to improve hypertension control. J Med Internet Res. 2011 Jan 20;13(1):e1. doi: 10.2196/jmir.1625.

    PMID: 21371993DERIVED

  • Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.

    PMID: 18577730DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Beverly B Green, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)